Final 510(k) Template Guidance Moves FDA Toward October 2023 Electronic Submission Mandate
September 21, 2022 at 07:32 PM EST
With the finalization of agency guidance on its electronic template for premarket notification (510(k)) submissions and an Oct. 3 invitation to all device firms to use the template, the FDA took major steps toward requiring that all 510(k)s be submitted electronically beginning in October 2023.
The final guidance, “Electronic Submission Template for Medical Device 510(k) Subm... Read More
